Acute Knee PainNCT03511014
Efficacy of Microcurrent Therapy for Treatment of Knee Pain
A study testing Microcurrent in people with Acute Knee Pain, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Acute Knee Pain
- What is being tested?
- Microcurrent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain perceived as a minimum of 3/10 on a 0-10 pain scale
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- Injury that began prior to 6-weeks ago before the onset of pain
- Grade II soft tissue injury
Who cannot join
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled HTN
- Past surgery in the region to be treated by microcurrent
Show all 13Show fewer
- Arthritis (RA) in the area to be treated by microcurrent
- Cardiovascular disease
- Allergic to tape/electrodes
- Ligament injury
- Patella Femoral Pain Syndrome (Anterior knee pain)
- Dementia
- Grade III soft tissue injury
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Omron healthcare Co.,Ltd.
Mukō
Shozo Takamatsu, +81-75-925-2043, shozo_takamatsu@ohq.omron.co.jp
Keisuke Yamada, +81-75-925-2043, keisuke_yamada@omron.co.jp
About this study
The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain.
- Conditions
- Acute Knee Pain
- Being tested
- Microcurrent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocurrentDevice
Micrucurrent will be apply
| Study group | Role | What they receive |
|---|---|---|
| microcurrent | Experimental | Not described Receives: Device: Microcurrent |
| control | Sham comparator | Not described Receives: Device: Microcurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain scale (NRS) for pain (0-10)
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Mar 2018
- Primary completion31 Jul 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elon University, Department of Physical Therapy Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511014
- Sponsor's protocol ID
- HI794-0001
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microcurrent Therapy for Treatment of Knee Pain
- ClinicalTrials.gov ID
- NCT03511014
- Acronym / sponsor ID
- HI794-0001
- Conditions
- Acute Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Elon University, Department of Physical Therapy Education
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microcurrent | Experimental | Device: Microcurrent |
| control | Sham comparator | Device: Microcurrent |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain perceived as a minimum of 3/10 on a 0-10 pain scale
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- Injury that began prior to 6-weeks ago before the onset of pain
- Grade II soft tissue injury
Key exclusion criteria (13 listed)
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled HTN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrocurrentMicrucurrent will be apply | Device | control, microcurrent |
Primary outcome
Numeric Pain scale (NRS) for pain (0-10)
Time frame: 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent in people with Acute Knee Pain, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain scale (NRS) for pain (0-10) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.